Cleared Traditional

INION CPS ORBITAL PLATES (K122890) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122890 · Inion OY · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
131d
Days
Class 2
Risk

K122890 is an FDA 510(k) clearance for the INION CPS ORBITAL PLATES. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on January 29, 2013 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Inion OY devices

Submission Details

510(k) Number K122890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2012
Decision Date January 29, 2013
Days to Decision 131 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 127d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 96
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K122890.
Stryker Universal Mesh
K170773 · Stryker · Nov 2017
Stryker Upper-Face AXS screws and Mid-Face AXS screws
K172572 · Stryker · Oct 2017
MP LeFort I Plates
K171364 · Stryker · Jul 2017
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · Medtronic Sofamor Danek USA, Inc. · May 2012
ARCHITEX SPACE MAINTENANCE SYSTEM
K110259 · Medtronic Sofamor Danek USA, Inc. · Apr 2011
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
K102656 · Synthes (Usa) · Dec 2010